Effectiveness of a cognitive behavioural therapy

Raftery et al. Trials 2013, 14:290
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STUDY PROTOCOL
TRIALS
Open Access
Effectiveness of a cognitive behavioural
therapy-based rehabilitation programme
(Progressive Goal Attainment Program) for
patients who are work-disabled due to back pain:
study protocol for a multicentre randomised
controlled trial
Miriam N Raftery1,2, Andrew W Murphy3, Eamon O’Shea4,5, John Newell6 and Brian E McGuire1,2*
Abstract
Background: Psychologically informed rehabilitation programmes such as the Progressive Goal Attainment
Program (PGAP) have the potential to address pain-related disability by targeting known psychological factors that
inhibit rehabilitation progress. However, no randomised controlled trials of this intervention exist and it has not
been evaluated in the Irish health service context. Our objective was to evaluate the clinical efficacy and
cost-effectiveness of the PGAP in a multicentre randomised controlled trial with patients who are work-disabled
due to back pain.
Methods and design: Adult patients (ages 18 years and older) with nonmalignant back pain who are work-disabled
because of chronic pain and not involved in litigation in relation to their pain were invited to take part. Patients were
those who show at least one elevated psychosocial risk factor (above the 50th percentile) on pain disability, fear-based
activity avoidance, fatigue, depression or pain catastrophizing. Following screening, patients are randomised equally to
the intervention or control condition within each of the seven trial locations. Patients allocated to the control condition
receive usual medical care only. Patients allocated to the PGAP intervention condition attend a maximum of 10 weekly
individual sessions of structured active rehabilitation in addition to usual care. Sessions are delivered by a clinical
psychologist and focus on graded activity, goal-setting, pacing activity and cognitive-behavioural therapy techniques
to address possible barriers to rehabilitation.
The primary analysis will be based on the amount of change on the Roland Morris Disability Questionnaire
posttreatment. We will also measure changes in work status, pain intensity, catastrophizing, depression, fear avoidance
and fatigue. Outcome measures are collected at baseline, posttreatment and 12-month follow-up. Health-related
resource use is also collected pre- and posttreatment and at 12-month follow-up to evaluate cost-effectiveness.
Discussion: This study will be the first randomized controlled trial of the PGAP in chronic pain patients and will
provide important information about the clinical and cost effectiveness of the programme as well as its feasibility in
the context of the Irish health service.
Trial registration: Current Controlled Trials: ISRCTN61650533
Keywords: Active rehabilitation, Back pain, Cognitive-behavioural therapy, Return to work
* Correspondence: [email protected]
1
School of Psychology, National University of Ireland, Galway, Ireland
2
Centre for Pain Research, National University of Ireland, Galway, Ireland
Full list of author information is available at the end of the article
© 2013 Raftery et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Raftery et al. Trials 2013, 14:290
http://www.trialsjournal.com/content/14/1/290
Background
Back pain constitutes a major health problem. In Ireland,
between 13% and 36% of the population have chronic
pain, with back pain being the most frequently reported
site of pain [1,2]. Importantly, of those who consult their
general practitioner (GP) for chronic pain, 60% to 80% still
have pain and disability 1 year later [3,4]. The economic
burden associated with chronic pain is also considerable.
Recent research has estimated the cost of chronic pain at
€5.34 billion, or 2.86% of gross domestic product per year
in Ireland [5], with a large proportion of these costs being
attributable to wage replacement for those unable to work
because of back pain. Over the past decade, research has
consistently highlighted the importance of psychological
factors in the development and maintenance of back pain
disability [6]. Specifically, fear avoidance beliefs [7], low
mood [8] and a cognitive process known as catastrophizing
[9] are consistently related to poor outcome [10,11]. There
is evidence that these variables may play an important role
in maintaining disability beyond the expected recovery time
for soft-tissue injury and may be significant barriers to
activity involvement and successful rehabilitation [12].
Although some reviews have shown only modest results
for the success of interventions that target psychosocial
risk factors [10,13], improvements in patient outcomes
have been demonstrated when subgrouping has been used
to guide treatment [14,15]. This subgrouping, or ‘matching’,
of patients to different treatment options on the basis of
psychological risk factors [14] has demonstrated that
psychologically informed management can result in both
health and economic benefits.
One such psychologically informed pain rehabilitation
programme is the Progressive Goal Attainment Program
(PGAP) [12,16]. PGAP and its predecessor the Pain
Disability Prevention (PDP) program (under which name
this trial was originally registered) were designed in Canada
to reduce long-term disability arising from pain and
other health conditions. PGAP is a manual-driven,
10-week rehabilitation programme designed to target
evidence-based psychosocial risk factors for pain-related
disability. These risk factors include fear-avoidance beliefs,
pain catastrophizing, perceived injustice and depression.
One of the most important components of this programme
is activity mobilization. It has been acknowledged [12],
however, that the predominately physical conceptualization
of activity mobilisation may account for the relative lack of
rehabilitation success for some patients [17]. Therefore, the
role of psychological factors in facilitating and impeding
activity mobilisation may have been underestimated. It has
been argued [12] that activity mobilization is a form of
behaviour change, one that involves a complex interplay
among several psychological variables. The incorporation of
psychological techniques to promote activity mobilisation is
the basis for the PGAP.
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The PGAP has proven efficacy in reducing disability and
promoting return to work among people with work-related
musculoskeletal pain [16] and whiplash injury [18].
However, there has not yet been a randomized controlled
trial of PGAP in a chronic pain population. Thus, there is
a need for an RCT study in which this rehabilitation
programme (plus usual medical treatment) is compared to
usual medical treatment alone. In addition, the PGAP has
been developed in the context of a highly systematic and
structured worker’s compensation system in Canada, but
Ireland does not have a formal worker’s compensation
system or rehabilitation case management. There is also
very little access to psychologically informed back pain
interventions at a community level in Ireland. Most
routine pain management is provided by primary care
GPs and physiotherapists who work in the public and
private sectors and generally offer generic treatment
services. However, there are virtually no other communitybased pain management services in Ireland. Ireland does
not have a national policy on the management of pain,
nor does it have any general practice guidelines for
the management of pain [19]. In the absence of a systematic pain management infrastructure in the community,
the evaluation of a service that could be provided over
and above normal primary care provision would seem
highly valuable.
The present study was designed to examine the effectiveness of this psychologically based rehabilitation programme
with a view to bridging this gap in service provision. We
also propose to conduct a qualitative study with those
receiving PGAP and the primary referral sources to get
feedback on the user-friendliness of the programme, since
establishing the feasibility of the programme is a specific
objective.
The rationale for an economic evaluation of the PGAP
is evident when one looks at the costs of long-term pain
and associated disability [2,20]. Even a small reduction
in the number of people with chronic disability is
expected to be highly cost-effective and to greatly reduce
the personal burden on those affected by chronic pain
[20,21]. The study proposed herein will include a detailed
cost–benefit analysis of the intervention as well as an analysis of its cost-effectiveness in terms of any cost savings
associated with reduced disability. This will include an
evaluation of both direct and indirect costs.
In summary, the study described herein has the following aims: (1) to examine the feasibility of implementing a
community-based psychological pain rehabilitation programme (PGAP) aimed at treating patients who show elevated psychosocial risk factors for long-term pain-related
disability, (2) to assess the effectiveness of the programme
in a randomised controlled trial comprising PGAP plus
medical treatment as usual (MTAU) versus MTAU only,
(3) to determine the costs and cost savings associated with
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the programme by utilising appropriate indicators of healthrelated costs, (4) to gather feedback about the programme
from key stakeholders and (5) to determine whether
any changes achieved as a result of the programme
are maintained at 12-month follow-up.
Methods and design
This PGAP study is a pragmatic, multicentre randomised
controlled trial of a cognitive behavioural therapy–based
active rehabilitation programme for patients who are
work-disabled due to back pain.
Setting
The trial intervention is delivered by clinical psychologists
based in eight regions of the Republic of Ireland: Galway,
Mayo, Sligo, Donegal, Limerick, Cork and Dublin. The
coordinating centre is the Centre for Pain Research at the
National University of Ireland, Galway (NUI Galway),
involving the academic departments of psychology,
general practice, economics and the HRB Clinical Research
Facility Biostatistics Unit. The intervention programme,
PGAP, is delivered by public sector clinical psychologists
based in each region. However, trial management and data
collection take place at the Centre for Pain Research at
NUI Galway.
Hypothesis
The primary objective of the present study is to evaluate
whether patients with back pain who take part in the
PGAP (intervention group) show a greater mean reduction
in reported disability compared to those who receive
MTAU only (control group). Secondary objectives are (1)
to examine changes in work status postintervention among
those in the intervention group compared with the change
in those in the control group (2) to examine changes in
psychological variables among those in the intervention
group compared to those in the control group and (3) to
examine the cost-effectiveness of the programme to assess
whether the costs of treatment are less than the savings
associated with better outcomes.
Recruitment and eligibility
Recruitment
Potential participants are recruited directly from GPs
and via self-referral (Figure 1). GP practices in Galway,
Sligo, Limerick, Donegal, Cork, Mayo and Dublin were
approached and informed about the study. The trial was
also advertised in the local media at each trial location
and within physiotherapy and primary care practices.
These announcements offered patients the option to
contact the research team directly if they were interested
in taking part in the trial. Patients who contacted the
research team directly were initially interviewed briefly
over the phone by the researcher involved in the trial.
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Those who fit the initial inclusion criteria (see below) were
given a brief explanation of what the trial involved and
were then sent a detailed information leaflet explaining all
aspects of the trial. The information leaflet also contained
two consent forms, one to be signed by the patient and
one to be signed by the patient’s GP. Patients were asked
to bring this information leaflet and the consent form to
their GPs. Each GP was asked to sign the consent form to
confirm the patient’s medical suitability to take part in
the trial.
Patients who are referred to the trial by their GP
are given the information leaflet and consent form, as
described above, by their GP at consultation. Both
consent forms are then returned to the research team.
When the research team receives the signed consent
form from both patient and GP, formal assessment
measures are then sent to the patient to screen for
the presence of elevated psychosocial risk factors.
Inclusion criteria
Participants are patients with nonmalignant back pain
18 to 65 years of age who are not working or working
no more than 50% of their usual work hours because of
nonmalignant back pain. Back pain must be present for
at least 6 weeks. GPs must confirm the presence of the
painful condition and approve their patients’ participation
in an activation programme.
Exclusion criteria
Patients are not eligible to participate in the trial if they
meet any of the following exclusion criteria. (1) The GP
confirms the presence of ‘red flags’ indicating serious
pathology (for example, cancer, fracture, infection). (2) The
patient has serious cognitive and psychiatric comorbidity.
This criterion will include patients who have a diagnosis of
a serious axis 1 or axis 2 mental health disorder as defined
by the Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition (DSM-IV). (3) The patient
has a cognitive impairment that may affect the ability
to engage in the programme (for example, Alzheimer
disease, aphasia, stroke). The presence of these conditions
will be confirmed by the patient’s GP. (4) The patient is
currently receiving psychological management for pain. (5)
The patient is involved in litigation in relation to the injury.
Ethical approval
The final study protocol and the final version of the
written informed consent form were approved by the NUI
Galway Research Ethics Committee (Ref 09/NOV/10).
Approval was also granted by individual hospital ethics
committees at each trial site. The procedure set out in this
protocol was designed to ensure that all persons involved
in the trial abide by good clinical practice and by the
ethical principles described in the current revision of
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Patient consults GP with back pain
Enrolment
Patient contacts research team directly
Researcher confirms patient suitability
based on trial inclusion criteria.
Patient does not fit trial inclusion
criteria: Patient not included
Patient fits trial inclusion criteria:
Sent PIL including patient and GP consent
forms
GP assesses patient medical suitability
Patient does not fit trial inclusion criteria
and/or shows red flags:
Patient not included
GP confirms medical suitability. Patient
and GP sing consent forms confirming
participation
Signed consent forms from patient and GP
received by research team
Baseline
Assessment
Patient is sent baseline questionnaires:
-Psychosocial risk factors.
-Health service use, medication
Patient shows no psychosocial risk
factors: Patient not included
Randomisation
Patient shows elevated psychosocial risk
factors
Intervention condition: PGAP plus
treatment as usual (N=70)
Control Condition: treatment as usual only
(N=70)
Mid-treatment assessment
Follow-up at end of treatment &
12 months.
Follow-up 10 weeks post baseline &
12 months.
Figure 1 Flowchart of patient recruitment.
the Declaration of Helsinki. Patients are required to sign a
written consent form before being admitted to the clinical
trial. The patient’s GP must also consent that the patient
is medically suitable to take part in the research.
Sample size
Following published guidelines [22], the sample size
calculation was based on having 80% power at the
5% significance level to detect a difference in mean
post-treatment improvement of 3 units or more on
the Roland-Morris Back Pain Questionnaire between
the control and intervention groups, assuming that the
standard deviation of the improvement is 6.1 units in both
groups [14]. In order to ensure sufficient power to detect
such a difference, a sample size of 60 is needed for each
arm. However, allowing for an attrition rate of 15% [16],
and based on the experience of Sullivan et al. (personal
communication MJ Sullivan, September 2007), we aim to
include 140 participants (70 per group) in the study and
expect to have complete data for about 120 participants
following dropouts.
Screening of larger numbers of patients will be required
to obtain a sample of 140. On the basis of recent research
examining the prevalence of psychosocial risk factors
among a general practice population, where at least one
factor was found in 24% of respondents and up to 52%
had a particular risk indicator, we expect that 20% to
50% of our sample frame will have one or more of the
psychosocial risk factors [23].
Screening measures
Patients who have returned written consent forms will be
asked to complete a postal questionnaire pack containing
measures of psychosocial risk factors and economic evaluation. Data will be collected from patients at baseline
(prerandomisation), midtreatment (intervention group only,
as this is part of the PGAP protocol), posttreatment
(or at 10 weeks postbaseline for controls) and 12-month
follow-up via postal questionnaire.
The primary outcome measure will be post-intervention changes in pain disability and work status
post-treatment. Specific outcome measures were selected on the basis of the targeted psychosocial risk
factors and on the Initiative on Methods, Measurement,
and Pain Assessment in Clinical Trials (IMMPACT)
recommendations for outcome measures for chronic
pain clinical trials [24]. These measures include the
following: (1) Roland-Morris Disability Questionnaire
[25], (2) Chronic Pain Grade Questionnaire [26], (3)
Short-Form McGill Pain Questionnaire [27], (4) Pain
Catastrophizing Scale [28], (5) Fear-Avoidance Beliefs
Questionnaire [29], (6) Hospital Anxiety and Depression
Scale: Depression Subscale [30] and (7) Fear and Fatigue
Questionnaire [12].
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Medication and health service use
Medication and health service use will be measured at
baseline, posttreatment and follow-up for all patients.
They will be measured using the pain version of the
Client Service Receipt Inventory (CSRI) [31]. This will
provide information on medication and health service
resource use. The CSRI has been used widely in economic
cost-of-illness studies, including studies of chronic pain
[5,32,33], and has been validated as an accurate measure
of frequency of health service use [34]. Medication use is
likely to vary throughout the trial duration, and GPs
will be allowed to vary medication as they see fit.
However, change in medication use will be measured
in post-treatment analysis. In cases of potential dual-use
medication being taken by a patient, we will, with the
patient’s consent, confirm with the prescribing GP if
the medication was prescribed for pain or otherwise.
Additional information will be gathered on (1) demographic variables (age, education, marital status); (2)
pain-related information (duration of pain, number of
pain sites, recurrence of pain, previous attendance at
a pain management programme); and (3) details of any
comorbid health conditions.
A patient is deemed suitable to go forward to the
treatment allocation stage of the trial based on the
presence of elevated psychosocial risk factors. This is
defined as a score above the 50th percentile on any
of the five risk factors targeted by the intervention:
catastrophizing (Pain Catastrophizing Scale), fear of
movement (Fear-Avoidance Beliefs Questionnaire), disability (Roland-Morris Disability Questionnaire), depression (Hospital Anxiety and Depression Scale) and fatigue
(Fear and Fatigue Scale).
Randomisation and treatment allocation
Eligible participants (that is, those who show elevated
psychosocial risk factors) will be randomly assigned by
computer-generated block randomisation to ‘intervention’
(PGAP sessions plus MTAU) or ‘control’ (MTAU only).
We expect 20 participants to take part in the trial in each
of the seven trial centres. Therefore, block randomisation
with variable block sizes is used to minimize the occurrence of chance imbalance in allocation to treatment and
control and to preserve unpredictability. The sequence of
the different blocks is predetermined by an independent
researcher not involved in the trial and concealed to
all investigators. The blocks are generated separately
for the different study sites so that stratification
according to trial centre can be performed. It was decided to stratify on trial centre only for pragmatic
reasons. Stratifying on additional variables, although
useful, would have called for a larger sample. As each
treating psychologist was seeing these trial patients in
addition to their usual caseload, a limit was placed on
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the number of patients each clinician would be asked
to see, thus limiting stratification.
Progressive Goal Attainment Program
The PGAP is a 10-week one-to-one rehabilitation programme delivered in this trial by clinical psychologists.
Each session is 1 hour long. The intervention was specifically designed to assist those individuals with thought
patterns and behaviours which are known to increase risk
for chronic disability. Patients are offered a maximum of 10
individual appointments with the PGAP psychologist. At
their first appointment, patients receive an instructional
DVD which orientates them to the PGAP and explains the
importance of activity mobilization. Through the course of
the treatment programme, the PGAP clinician assists the
patient in identifying ways to increase activity involvement.
Working with the PGAP clinician, the patient develops an
activity schedule that is designed to keep him or her as
active as possible. This may include household activities,
running errands and social and recreational activities. A
central element is a programme of regular walking. The
patient’s spouse or partner is invited to participate in
activity planning so that he or she is aware of the
program that is being developed for the patient.
In the second phase of the program, the patient
develops skills to overcome fears of reinjury and learns
to monitor and modify self-defeating thinking that may
accompany pain. The patient is taught methods of
approaching physical activity in a way that minimizes
worries and concerns about potential reinjury by using
cognitive behavioural therapy strategies. Specifically, the
programme addresses functional activity scheduling,
activity pacing and psychological obstacles to progress such
as fear of movement and reinjury, pain catastrophizing and
the impact of negative or pessimistic thinking on emotional
well-being and activity level. Finally, the patient learns
communication skills and problem-solving strategies that
will assist him or her in meeting the challenges brought on
by the injury.
A total of 11 clinical psychologists employed in the
public health service were trained to deliver the PGAP.
This training involved attending a 2-day workshop delivered
by the developer of the intervention (MJ Sullivan, McGill
University, Montreal, QC, Canada). The psychologists
involved in the trial are spread geographically throughout
the Republic of Ireland and will see patients as part of this
trial in their usual clinics.
Patients who have been randomly assigned to the
intervention condition are contacted by the researcher
involved in the trial to discuss their participation. An
appointment is arranged with a PGAP psychologist who
is geographically closest to the patient. Each patient is
seen for a maximum of 10 hourlong one-to-one appointments with the PGAP psychologist. In parallel with these
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sessions, patients are free to access their GP and any other
healthcare professional as usual. Patients are offered a
maximum of 10 sessions with the clinical psychologist as
part of the PGAP. Each patient is given a copy of the
Client Manual, a workbook of exercises to be completed
as part of the programme. The programme may be terminated earlier if the patient is able to return to work before
attending all 10 sessions. Termination of treatment
before the end of the 10 sessions will be at the discretion of each psychologist in consultation with the
patient and patient’s GP.
Control condition
Patients allocated to the control condition do not receive
the PGAP. The patient is contacted by the researcher to
explain that they have been allocated to the control
condition and what this means. This gives the patient an
opportunity to ask questions. This step is followed by
written confirmation of the patient’s allocation to the
control group. Patients in the control condition are free
to access all healthcare services as usual. Patients who
are randomised to the control condition will not be
precluded from enrolling in a psychological pain management programme for the duration of this trial. If
this happens, however, their data will be excluded
from analysis. Participants in the control condition
are sent assessment measures at baseline and at
10 weeks postbaseline. It is recognized that GP care
will vary from individual to individual.
Quantitative analysis
Patients participating in the PGAP trial are heterogeneous
in terms of specific back pain problems, length of time in
pain, history of attending pain management programmes
and current medical management, including medication.
Therefore, participating patients’ age, gender, marital
status, length of time in pain, medical diagnosis (if any),
number of pain sites, previous medical or therapeutic
procedures and current medication is be gathered as
potentially useful explanatory variables in all analyses.
The longitudinal change in the response variables of
interest across treatment arms will be analysed using a linear mixed model to compare the change within individual
participants (that is, before and after the intervention) and
between the study arms (that is, comparing the cohort of
patients who received the PGAP intervention to the control group participants), adjusting for baseline, treatment
centre and patient characteristics as necessary. It will be
assumed that missing data are missing at random, and the
sensitivity to this assumption will be assessed using
multiple imputations based on chained equations [35].
The selection of explanatory variables for inclusion in
all final models will be based on a combination of clustering, tree-based methods and variable selection techniques
Page 6 of 8
applied to the complete cases and to the imputed data. All
analyses will be carried out using R software [36] and
SPSS software (SPSS Inc, Chicago, IL, USA) as necessary.
Model-checking will be performed using suitable
model diagnostics and residual plots. Sensitivity analysis
will be used to explore whether adherence to the intervention influences the effect of the intervention on the
primary outcome.
Qualitative analysis
Following the randomised controlled trial, qualitative
research will be undertaken to explore the perceptions,
views and experiences of patients and clinicians who
participated and delivered the PGAP. Semistructured
one-to-one interviews will be conducted with 15 participants and all clinicians within 3 months of completion
of the PGAP. Participants will be purposively selected to
ensure that a representative range of characteristics such
as age and length of time in pain are taken into account.
All interviews will be recorded and transcribed, and
data analysis will be based on themes derived from
the transcripts. NVivo, a qualitative software package
(QSR International, Doncaster, VIC, Australia), will be
used to facilitate data management and analysis.
Economic analysis
Economic evaluation will consist of a standard cost–benefit
analysis. An incremental analysis of cost-effectiveness will
also be conducted to compare the costs and outcomes of
the intervention to those in the control group. By establishing the costs of the programme and the associated
health benefits, we can infer the cost-effectiveness of the
intervention. Use of healthcare and social care services will
be documented on the basis of questionnaire data obtained
from the patients. We will collect two primary types of data
on the economic impact of chronic pain: (1) the costs
falling on healthcare and social care systems and (2) the
costs falling on individuals and employers. Factors that
contribute to costs include hospital visits, GP visits,
medicines and other treatments. Intangible costs such
as reduced quality of life will be extrapolated from
international studies. The assessment of the opportunity
cost of work will be based on days lost due to pain using
information from the Central Statistics Office in Ireland.
Family costs will also be documented and valuated in
monetary terms. Costs to families will include time off
from work to care for relatives with pain difficulties and
direct costs such as fuel, use of cars and any treatments
not covered by the state or insurance bodies. Unit costs
will be calculated linking resource use to the best available
cost data. In the case of hospital services, resource use will
be assessed using diagnosis-related group unit costs. The
cost of GP care will be calculated using the medical card
capitation rates and the average charges for non–medical
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card patients. Costs to individuals and families will be
calculated using average wage and other direct costs, such
as travel costs. Uncertainty in the analysis will be explored
using a combination of univariate and multivariate
sensitivity analyses, and decision uncertainty will be
addressed using cost-effectiveness acceptability curves.
Trial status
At the time of submission of this protocol (March 2013),
enrolment into the study was ongoing. Recruitment
was completed in May 2013 with collection of follow-up
data ongoing.
Page 7 of 8
6.
7.
8.
9.
10.
11.
Competing interests
The authors declare that they have no competing interests.
12.
Authors’ contributions
MR is involved in trial management, recruitment, and acquisition of baseline
data and drafted the manuscript. AM is involved with patient recruitment
and monitoring of the study. EOS oversees the health economics aspect of
the study. JN oversees the statistical aspects and analysis of the study. BMcG
designed the intervention, supervises the study, and contributed to editing
the manuscript. All authors read and approved the final manuscript.
Authors’ information
MR is a researcher in the Centre for Pain Research and School of Psychology
at the National University of Ireland, Galway (NUI Galway). AM is Professor of
General Practice at NUI Galway. EOS is Professor at School of Economics and
the Centre for Social Gerontology at NUI Galway. JN is Senior Lecturer in
Biostatistics at the HRB Clinical Research Facility, NUI Galway. BMcG is Senior
Lecturer in Clinical Psychology and Co-Director, Centre for Pain Research at
NUI, Galway and Principal Investigator of the study.
13.
14.
15.
16.
17.
Acknowledgement
Funding was received from the Health Research Board, Ireland.
18.
Author details
1
School of Psychology, National University of Ireland, Galway, Ireland. 2Centre
for Pain Research, National University of Ireland, Galway, Ireland. 3Discipline
of General Practice, National University of Ireland, Galway, Ireland.
4
Department of Economics, National University of Ireland, Galway, Ireland.
5
Irish Centre for Social Gerontology, National University of Ireland, Galway,
Ireland. 6HRB Clinical Research Facility and School of Mathematics, Statistics
and Applied, Mathematics, National University of Ireland, Galway, Ireland.
Received: 20 March 2013 Accepted: 2 August 2013
Published: 11 September 2013
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doi:10.1186/1745-6215-14-290
Cite this article as: Raftery et al.: Effectiveness of a cognitive
behavioural therapy-based rehabilitation programme (Progressive
Goal Attainment Program) for patients who are work-disabled due to back
pain: study protocol for a multicentre randomised controlled trial. Trials
2013 14:290.
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